ISO9001供应商审核检查表英文版.docx
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ISO9001供应商审核检查表英文版.docx
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ISO9001供应商审核检查表英文版
Guidance
AboutthisChecklist
Theauditchecklistisjustoneofthemanytoolswhichareavailablefromtheauditor’stoolboxthathelpensureyourauditsaddressthenecessaryrequirements.Itstandsasareferencepointbefore,duringandaftertheauditprocessandifdevelopedforaspecificauditandusedcorrectlywillprovidethefollowingbenefits:
∙Ensurestheauditisconductedsystematically;
∙Promotesauditplanning;
∙Ensuresaconsistentauditapproach;
∙Activelysupportsyourorganization’sauditprocess(ISO9001:
2015,Clause9.2.1);
∙Providesarepositoryfornotescollectedduringtheaudit;
∙Ensuresuniformityintheperformanceofdifferentauditors;
∙Providesreferencetoobjectiveevidence.
Thisauditchecklistcomprisestablesofthecertifiable(‘shall’)requirements,fromSection4.0toSection10.0ofISO9001:
2015,eachrequiredisphrasedasaquestion.Thisauditchecklistmaybeusedforelementcomplianceauditsandforprocessaudits.Ifyouwishtocreateseparateprocessauditchecklists,selecttheclausesfromthetablesbelowthatarerelevanttotheprocessandcopyandpastetheauditquestionsintoanewauditchecklist.Wesuggestthatyouretainthisauditchecklistasyour‘mastercopy’.
AuditScoringCriteria
Arisk-basedinternalauditapproachallowstheinternalaudittoconcentrateonreviewingthemajorriskstoyourorganization.Theaudit’sroleistoprovideassurancethatkeyriskstoyourorganization’sobjectivesarebeingwellcontrolled.
Theauditfindings‘trafficlights’areintendedtovisuallycommunicatetheriskposedbytheauditfindingofanysystemorprocessesbeingaudited.Theratingsystemisstratifiedfrom‘compliant’to‘majornon-conformance’toconveyaconciseandconsistentmethodforscoringeachauditfinding.Attheendoftheaudit,youcantransferthefindingsintoanExcelspreadsheettocreatecharts,summarytablesandtrenddatatopasteintoyourauditreportormanagementreviewdocumentation.
Thismethodologyshouldbeuniformlyappliedtoalltypesofinternalaudit(gapanalysis,systemauditsandprocessaudits)thatyourorganizationwilllikelyundertake.
Finding
Definition/Impact
Action/Mitigation
COMPLIANT
CompliantmeansadherencewiththerequirementsofthestandardandtheQMS.Theprocessisimplementedanddocumentedandrecordsexisttoverifythis.
Continuetomonitortrends/indicators.
OFI
Alowriskissuethatoffersanopportunitytoimprovecurrentpractice.Processesmaycumbersomeoroverlycomplexbutmeettheirtargetsandobjectives.UnresolvedOFIsmaydegradeovertimetobecomenon-compliant.
Reviewandimplementactionstoimprovetheprocess(s).Monitortrends/indicatorstodetermineifimprovementwasachieved.
MINORN/C
Amediumrisk,minornon-conformanceresultingindeviationfromprocesspracticenotlikelytoresultinthefailureofthemanagementsystemorprocessthatwillnotresultinthedeliveryofnon-conformingproductsnorreducetheeffectivenessoftheQMS.
Investigaterootcause(s)andimplementcorrectiveactionbynextreportingperiodornextscheduledaudit.
MAJORN/C
Ahighrisk,majornon-conformancewhichdirectlyimpactsuponcustomerrequirements,likelytoresultinthecustomerreceivingnon-conformingproductsorservices,orwhichmayreducetheeffectivenessoftheQMS.
Implementimmediatecontainmentaction,investigaterootcause(s)andapplycorrectiveaction.Re-auditin4weekstoverifycorrection.
ProcessActivityMap
SupplierAuditQuestions
QualityManagement
Ref
AuditQuestion
AuditFindings
(Score‘1’perbox)
AuditEvidence
Opportunitiesfor
Improvement(OFI)
COMPLIANT
OFI
MINORN/C
MAJORN/C
Providereferencetodocumentedinformationtojustifythefinding
Providesuggestionsforprocessimprovement
1
Isthequalitysystemdocumented,controlledandmaintainedtoclearlydescribecurrentpractice?
Qualitymanualandallproceduresshowrevisioncontrol(sign-offs&dates),historyofchanges
2
Doqualityreports,trendchartsanddataanalysisidentifyareasofopportunityandareusedbymanagementonaroutinebasis?
Productqualityyielddata,problemsandcorrespondingimprovementactions,statusofpreventive/corrective/auditresults
3
Arequality-performancetargetsclearlydefined,includedinthebusinessplanandmonitoredforimprovements?
Strategicandtacticalobjectives,goals,actionplans,etc.
4
Doesexecutivemanagementparticipateinperiodicqualitysystemreviewsthataddressqualityrelatedfeedbackfromcustomersandinternalqualitymetrics?
Analysisoffieldfailures,inspectionyields,resourceneeds,internalauditresults,correctiveactionstatus,etc.
ContinuousImprovement
Ref
AuditQuestion
AuditFindings
(Score‘1’perbox)
AuditEvidence
Opportunitiesfor
Improvement(OFI)
COMPLIANT
OFI
MINORN/C
MAJORN/C
Providereferencetodocumentedinformationtojustifythefinding
Providesuggestionsforprocessimprovement
5
Arepreventiveactionstakenbasedontheanalysisofsignificantbusinesstrends,designreviews,customersatisfactionsurveysorothermeaningfulinputs?
Managementreviewmeetings,goalsetting,performancemeasurement,internalaudits,actionplans,customersurveys
6
Isthereaformalapproachusedtoactivelypursuecostcontainmentandothercontinualimprovementactivitiesthroughouttheorganization?
Employeeinvolvement/recognitionprogram,Lean,SixSigma,kaizen,SPC,5-S,costreductionprogramme
7
Isacorrectiveactionsysteminplacethatprovidesrootcauseanalysisandtakestimelyandeffectiveactiontopreventrecurrence?
Correctiveactions,trendcharts,meetingminutes,non-conformancefrequency&costanalysis
8
Doesthecorrectiveactionsystemcovercustomer,internalandsupplierissues?
Managementreviewmeetingsandcorrectiveactions
Training&Awareness
Ref
AuditQuestion
AuditFindings
(Score‘1’perbox)
AuditEvidence
Opportunitiesfor
Improvement(OFI)
COMPLIANT
OFI
MINORN/C
MAJORN/C
Providereferencetodocumentedinformationtojustifythefinding
Providesuggestionsforprocessimprovement
9
Istheskillandeducationlevelrequiredforeachjobdocumentedandappropriatetrainingprovided?
Lookforuseoftrainingaidsandworkinstructionsatworkstations
10
Isemployeequalification/certificationmaintainedwherethequalityoutcomeoftheprocesscannotbeverifiedandisstronglydependentuponoperatorskill?
Qualificationrecords,certificationhistory
11
Aresuitablemethodsusedtoverifytrainingeffectiveness?
Recordsoftesting,productionqualityrecords,auditrecords,interviewworkerstovalidatetrainingrecords
12
Aresuitablerecordsofmaintained?
Jobdescriptions,jobskillsassessment,trainingrecords,trainingmanuals
Design&DevelopmentSupport
Ref
AuditQuestion
AuditFindings
(Score‘1’perbox)
AuditEvidence
Opportunitiesfor
Improvement(OFI)
COMPLIANT
OFI
MINORN/C
MAJORN/C
Providereferencetodocumentedinformationtojustifythefinding
Providesuggestionsforprocessimprovement
13
Arecustomerneedsandrequirementsincorporatedintoproductdesignsand/ormanufacturingprocesses?
Marketstudies,customer/end-usersurveys,technicaldesignreviews
14
AreCritical-to-Quality(CTQ)characteristicsareidentified,understoodandrecordsretained?
Processcapabilitystudies,processplan,manufacturingverificationtests
15
Areproductspecificationsanddrawingsgenerated,controlledandmaintainedforneworchangedproductdesigns?
Productcharacteristics,applicationrequirementsandotherinformationforsafeandproperuseanddisposal
16
Isdesignvalidationisanintegralpartofthedesignprocessandoccurspriortoproductionrelease?
Designresults,manufacturability,productivityandcoststudies,confirmationthatproductfulfilsitsspecifiedrequirementsorintendeduseorapplications
17
Arehumanandtechnicalresourcesareadequatetomeettherequirementsfordesigncollaboration,toolingdesignandelectronicdrawinganddataexchange?
Qualificationoftechnicalstaff.Equipment/softwarecapabilities,CAD
QualityPlanning
Ref
AuditQuestion
AuditFindings
(Score‘1’perbox)
AuditEvidence
Opportunitiesfor
Improvement(OFI)
COMPLIANT
OFI
MINORN/C
MAJORN/C
Providereferencetodocumentedinformationtojustifythefinding
Providesuggestionsforprocessimprovement
18
Areproductionsamplesinspectedandprovidedtocustomersuponrequest?
CompletedPPAPorsimilarforms,inspectionreports,availabilityofqualifiedresources
19
Arecustomerproductionrequirementsandqualityspecificationsarereviewedtoensuretheycanbemetonaconsistentbasis?
Procedures,design/processreview,capacityplans,resourceplans,producttest,storage,packagingandshipmentrequirements
20
Arereliabilitytestplansdevelopedandroutinelyfollowed?
Reliabilitytestplans,testreports
21
Istestingisusedtoverifythedesignspecifications,drivedesignimprovementsandprovideanon-goingcheckofmaterialsandworkmanship?
Improvement/correctiveactionstaken,designchangesimplemented
22
Isproductreliabilitytestdataisavailableuponrequestandhistoricaltestperformancedatashowsahighlystableprocessandproductdesign?
Reliabilitytestsummaryreports/charts
CustomerDocumentation
Ref
AuditQuestion
AuditFindings
(Score‘1’perbox)
AuditEviden
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